The Supreme Court ruled on Monday that makers of generic drugs already approved by the Food and Drug Administration cannot be held liable under state law for claims of design defects.
In a 5-4 vote, the court ruled for Mutual Pharmaceutical, a unit of URL Pharma, owned by Sun Pharmaceutical Industries. Justice Samuel Alito wrote the majority opinion.
Mutual had asked the nine-member court to overturn a $21 million jury award to Karen Bartlett, a New Hampshire woman who took Mutual's generic nonsteroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.
Bartlett suffered a rare hypersensitivity reaction three weeks after she started taking it. Her skin began to peel off, leaving her with burn-like lesions over two-thirds of her body.
Mutual, backed by the Obama administration, said that federal law trumped state law claims like those Bartlett had made, pointing to the fact that the drug already had won FDA approval.
Federal law requires generic drugs to have the same design as their brand-name equivalents, Mutual argued.
The case is Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142.